Impact of Educational Intervention Protocol on the Level of Knowledge, Clinical Control and Lung Function of People With Asthma

Not Applicable

Recruiting

• Conditions: Asthma

• Registration Number: NCT06878352
• Lead Sponsor: Federal University of Paraíba

Brief Summary

The goal of this randomized controlled clinical trial is to evaluate the effects of a proposed educational intervention on people with asthma. The main question it aims to contribute to a better understanding of the effectiveness of educational intervention strategies in people with asthma.

Participants allocated to the control group will receive standard follow-up according to the clinic routine. Participants allocated to the experimental group will undergo an educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024).

Detailed Description

People with asthma will participate in the study, from the Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Paraíba - UFPB. Spirometry data, knowledge about asthma and correct control over inhalation therapy, clinical control of the disease using the Asthma Control Test (ACT) and C-ACT questionnaire, number of asthma attacks, amount of medication used, hospitalizations and visit to the emergency room in the last 4 weeks will be assessed. Assessments will be carried out at the first contact (baseline) and twelve weeks after the first contact.

Study Timeline

• Study First Submitted: 2025-02-19
• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-07
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Clinical diagnosis of asthma
• Assisted by the Pulmonary Function Clinic
• Ventilatory dysfunction assessed by spirometry

Exclusion Criteria

• Obesity
• Treatment with systemic corticosteroids
• Previous chest surgery
• Unable to perform any of the proposed assessment steps

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
clinical asthma control	Baseline and 4 weeks	Asthma Control Test (ACT)/Childhood Asthma Control Test (C-ACT) score. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma.
Retention of information about asthma knowledge and inhalation therapy	Baseline and 4 weeks	Number of correct answers obtained from the asthma knowledge questionnaire at the end of the educational intervention

Secondary Outcome Measures

Name	Time	Method
hospitalizations and emergency room visits	Baseline and 4 weeks	number of hospitalizations and emergency room visits in the last four months
Pulmonary function - Spirometry	Baseline and 4 weeks	Predicted percentages of spirometric variables such as the values of Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) because the correlation between these values can indicate the presence of respiratory disorders such as asthma.

Trial Locations

Locations (1)

Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Paraiba; 🇧🇷 João Pessoa, Paraíba, Brazil